Ariz. Admin. Code § 9-9A-303

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-9A-303 - Security Standards; Inventory Controls

A. A licensee of a non-accredited procurement organization shall ensure that access to the enclosed-locked areas where non-transplant anatomical donations and non-transplant anatomical material are located is limited to individuals authorized by the licensee or administrator.

B. An administrator of a non-accredited procurement organization shall ensure that:

1. Standard operating procedures are developed, documented, and maintained to prevent unauthorized access to non-transplant anatomical donation or non-transplant anatomical material inventory that:

a. Restricts access to the areas of the building that contain non-transplant anatomical donations or non-transplant anatomical material inventory and donor records,

b. Provides for identification of authorized individuals, and

c. Specifies the methods for conducting electronic monitoring;

2. Personnel or security equipment to deter and prevent unauthorized entrance into limited access areas are present and operational and include:

a. Devices or a series of devices to detect unauthorized intrusion, which may include a signal system interconnected with a radio-frequency device or other mechanical or electronic devices;

b. Exterior lighting to facilitate surveillance; and

c. Electronic monitoring using video cameras to provide coverage of:

i. Entrances to and exits from limited access areas, and

ii. Entrances to and exits from the buildings;

3. Video recordings from the video cameras required in subsection (B)(2)(c) are retained for at least 30 calendar days;

4. The electronic monitoring system in subsection (B)(2)(c) has a failure notification system that provides an audible and visual notification of any failure in the electronic monitoring system; and

5. Battery backup is present and operational to ensure the functioning of video cameras and recording equipment in the event of a power outage.

C. A licensee of a non-accredited procurement organization shall establish and implement an inventory tracking system for non-transplant anatomical donations and non-transplant anatomical material that:

1. Contains information about all non-transplant anatomical donations received and non-transplant anatomical material released for distribution;

2. Includes release documentation related to requirements in R9-9A-201(B), and R9-9A-203(C) and (K), for each item of nontransplant anatomical material prior to transferring the item of non-transplant anatomical material to inventory;

3. Documents the date, time, and location for non-transplant anatomical material transferred for use, including:

a. The name of the individual performing the transfer, and

b. The name and contact information for an end-user or other person to which non-transplant anatomical material may be transferred;

4. Documents the date, time, and location for items of non-transplant anatomical material that are moved between locations controlled by the procurement organization, including the name of the individual overseeing the move; and

5. Ensures non-transplant anatomical material that can no longer be used is removed from inventory and disposed of according to applicable standard operating procedures for final disposition.

Ariz. Admin. Code § R9-9A-303

New Section made by final expedited rulemaking at 30 A.A.R. 3658, effective 11/5/2024.